免疫组织化学抗体检测，c-kit
PMA编号：P040011 · 2017-05-16
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决定日期2017-05-16
PMA 编号P040011
产品代码NKF
设备分类第3类
医疗专科H
法规编号21 CFR 8
咨询委员会PA
请注意，由于您没有提供具体的医疗设备监管文本，我无法提供准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。
器械摘要
Immunohistochemistry antibody assay, c-kit is the device name listed in this FDA 510(k) record. The listed applicant is Dako North America, Inc.. It received FDA 510(k) clearance on 2017-05-16. The device is classified under product code NKF. It was reviewed by the PA advisory panel.
常见问题
What is the Immunohistochemistry antibody assay, c-kit?
Immunohistochemistry antibody assay, c-kit is a medical device that received FDA 510(k) clearance on 2017-05-16. The listed applicant is Dako North America, Inc..
When did Immunohistochemistry antibody assay, c-kit receive FDA 510(k) clearance?
The clearance date for Immunohistochemistry antibody assay, c-kit can be found in the official FDA records.
Who is the listed applicant for Immunohistochemistry antibody assay, c-kit?
The FDA 510(k) record lists Dako North America, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Immunohistochemistry antibody assay, c-kit?
The FDA product code for Immunohistochemistry antibody assay, c-kit is NKF.
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官方来源
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